Chikungunya, Chikungunya Fever, Chikungunya Virus
Conditions
Keywords
Chikungunya virus, HydroVax, dose-ranging, double blind, placebo-controlled, vaccine
Brief summary
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 and Day 29 in up to 48 healthy adults healthy adults ≥ 18 and \< 50 years of age. The primary objective is to assess the safety and reactogenicity of the HydroVax-005 CHIKV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 2.5 mcg or a dose of 8 mcg.
Detailed description
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 (the day of first vaccination is defined as Day 1) and Day 29 in healthy adults ≥ 18 and \< 50 years of age. The study will consist of two dosing groups of HydroVax-005 CHIKV vaccine to be enrolled sequentially. Each dose group will consist of 20 individuals who receive HydroVax-002 YFV, as well as 8 total subjects who receive placebo. Each dose-group will include a sentinel subgroup consisting of 5 vaccine and 1 placebo recipient. In each of the two (2.5 mcg and 8 mcg) dose phases, enrollment is halted after the dose 1 vaccination of the sentinel subgroup. Following assessment of safety and reactogenicity data of Group 1 by the Internal Safety Review Committee (ISRC), the vaccine dose will be increased to 8 mcg for Group 2.
Interventions
BIOLOGICALHydroVax-005 CHIKV
HydroVax-005 CHIKV vaccine
OTHERPlacebo
NaCl 0.9%, Normal Saline
Sponsors
Najit Technologies, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Must agree to the collection of venous blood per protocol. 4. Are males or non-pregnant females, ≥18 and \<50 years of age, inclusive at time of enrollment. 5. Are in good health. As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject
Exclusion criteria
as well as herbals, vitamins and supplements are permitted. 6. Oral temperature is less than 100.0℉. 7. Pulse is 40 to 100 beats per minute, inclusive. 8. Systolic blood pressure is 90 to 140 mmHg, inclusive. 9. Diastolic blood pressure is 60 to 90 mmHg, inclusive. 10. Screening laboratories (White Blood Cell Count (WBC), Hemoglobin (Hgb), Platelet Count (PLTs), Sodium, Potassium, Bicarbonate, Calcium, Creatinine (Cr), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL) and urine protein and glucose) are within acceptable parameters. Hematology, blood chemistry and liver enzymes must be Grade 1 or less at screening; urine glucose negative and urine protein no greater than trace at screening for subjects to qualify for randomization and vaccination. 11. Negative test result at screening blood draw for hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) types 1 or 2 antibodies. 12. Women of childbearing potential must use an acceptable contraception method from at least 30 days before the first study vaccination until 30 days after the second study vaccination. Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, effective intrauterine devices, NuvaRing®, tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives (i.e. "the pill"). 13. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination. 14. Sexually active males must agree to use a medically acceptable form of contraception in order to be in this study and must agree to continue such use until day 90 after the last vaccination. Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of all serious adverse events (SAEs) at any time during the study | Day 1 post first vaccination to Day 180 post second vaccination | Occurrence of all serious adverse events (SAEs) at any time during the study |
| Incidence of Adverse Events of Special Interest (AESI) at any time during the study | Day 1 post first vaccination to Day 180 post second vaccination | Incidence of Adverse Events of Special Interest (AESI) at any time during the study |
| Occurrence of all Grade 3 unsolicited adverse events (AEs) from first vaccination through day 29 after the second vaccination | Through day 29 after the second vaccination | Occurrence of all Grade 3 unsolicited adverse events (AEs) from first vaccination through day 29 after the second vaccination |
| Occurrence of all Grade 3 laboratory toxicities from first vaccination through day 15 after the second vaccination | Through day 15 after the second vaccination | Occurrence of all Grade 3 laboratory toxicities from first vaccination through day 15 after the second vaccination |
| Occurrence of solicited local AE and reactogenicity signs and symptoms in the 7 days after each vaccination | Through 7 days after each vaccination | Occurrence of solicited local AE and reactogenicity signs and symptoms in the 7 days after each vaccination |
| Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 7 days after each vaccination | Through 7 days after each vaccination | Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 7 days after each vaccination |
| Occurrence of any AE through day 29 after the second vaccination | Through day 29 after the second vaccination | Occurrence of any AE through day 29 after the second vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects achieving seroconversion | At day 29 after first vaccination and at day 29 after second vaccination | Percentage of subjects achieving seroconversion (≥1:10 in plaque reduction neutralizing titer \[PRNT50\] titer, at day 29 after first vaccination and at day 29 after second vaccination |
| Geometric mean neutralizing titers | At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination | Geometric mean neutralizing titers at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination |
| Reverse cumulative distribution curve of neutralizing titers | At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination | Reverse cumulative distribution curve of neutralizing titers on Days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 after the second vaccination for each dose group and for all dose groups combined |
Countries
United States
Outcome results
None listed